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Ethical, legal, and social issues (ELSI) in rare diseases: a landscape analysis from funders.

Hartman AL, Hechtelt Jonker A, Parisi MA, Julkowska D, Lockhart N, Isasi R.

Eur J Hum Genet. 2019 Sep 19. doi: 10.1038/s41431-019-0513-3. [Epub ahead of print]


Regulating Preimplantation Genetic Testing across the World: A Comparison of International Policy and Ethical Perspectives.

Ginoza MEC, Isasi R.

Cold Spring Harb Perspect Med. 2019 Sep 10. pii: a036681. doi: 10.1101/cshperspect.a036681. [Epub ahead of print]


A pathway for attesting ethical provenance of cell lines: Lessons from the European human pluripotent stem cell registry (hPSCreg).

Isasi R, Namorado J, Mah N, Bultjer N, Kurtz A.

Stem Cell Res. 2019 Aug 19;40:101539. doi: 10.1016/j.scr.2019.101539. [Epub ahead of print] No abstract available.


Model consent clauses for rare disease research.

Nguyen MT, Goldblatt J, Isasi R, Jagut M, Jonker AH, Kaufmann P, Ouillade L, Molnar-Gabor F, Shabani M, Sid E, Tassé AM, Wong-Rieger D, Knoppers BM; IRDiRC-GA4GH Model Consent Clauses Task Force.

BMC Med Ethics. 2019 Aug 1;20(1):55. doi: 10.1186/s12910-019-0390-x.


The clinical application of gene editing: ethical and social issues.

Ormond KE, Bombard Y, Bonham VL, Hoffman-Andrews L, Howard H, Isasi R, Musunuru K, Riggan KA, Michie M, Allyse M.

Per Med. 2019 Jul;16(4):337-350. doi: 10.2217/pme-2018-0155. Epub 2019 Jul 23.


What do we do now?: Responding to claims of germline gene editing in humans.

Allyse M, Bombard Y, Isasi R, Michie M, Musunuru K, Ormond KE.

Genet Med. 2019 Oct;21(10):2181-2183. doi: 10.1038/s41436-019-0492-3. Epub 2019 Mar 27. No abstract available.


Debate ethics of embryo models from stem cells.

Rivron N, Pera M, Rossant J, Martinez Arias A, Zernicka-Goetz M, Fu J, van den Brink S, Bredenoord A, Dondorp W, de Wert G, Hyun I, Munsie M, Isasi R.

Nature. 2018 Dec;564(7735):183-185. doi: 10.1038/d41586-018-07663-9. No abstract available.


Assessing opportunities and challenges for establishing a national program to distribute cord blood for research.

Isasi R, Mastronardi C, Golder M, Allan D, Walker M, Halpenny M, Yang L, Elmoazzen H, Chargé S.

Transfusion. 2018 Jul;58(7):1726-1731. doi: 10.1111/trf.14602. Epub 2018 Apr 1.


Including all voices in international data-sharing governance.

Kaye J, Terry SF, Juengst E, Coy S, Harris JR, Chalmers D, Dove ES, Budin-Ljøsne I, Adebamowo C, Ogbe E, Bezuidenhout L, Morrison M, Minion JT, Murtagh MJ, Minari J, Teare H, Isasi R, Kato K, Rial-Sebbag E, Marshall P, Koenig B, Cambon-Thomsen A.

Hum Genomics. 2018 Mar 7;12(1):13. doi: 10.1186/s40246-018-0143-9.


A blueprint for the next generation of ELSI research, training, and outreach in regenerative medicine.

Illes J, Sipp D, Kleiderman E, Benjaminy S, Isasi R, Lomax G, Master Z, McCormick J, Ogbogu U, Ravitsky V, Robillard JM, Rossi F, Wilson B, Zarzeczny A.

NPJ Regen Med. 2017 Jul 5;2:21. doi: 10.1038/s41536-017-0026-z. eCollection 2017. Review.


Human gene editing: revisiting Canadian policy.

Knoppers BM, Isasi R, Caulfield T, Kleiderman E, Bedford P, Illes J, Ogbogu U, Ravitsky V, Rudnicki M.

NPJ Regen Med. 2017 Jan 5;2:3. doi: 10.1038/s41536-017-0007-2. eCollection 2017. No abstract available.


Report of the International Stem Cell Banking Initiative Workshop Activity: Current Hurdles and Progress in Seed-Stock Banking of Human Pluripotent Stem Cells.

Kim JH, Kurtz A, Yuan BZ, Zeng F, Lomax G, Loring JF, Crook J, Ju JH, Clarke L, Inamdar MS, Pera M, Firpo MT, Sheldon M, Rahman N, O'Shea O, Pranke P, Zhou Q, Isasi R, Rungsiwiwut R, Kawamata S, Oh S, Ludwig T, Masui T, Novak TJ, Takahashi T, Fujibuchi W, Koo SK, Stacey GN.

Stem Cells Transl Med. 2017 Nov;6(11):1956-1962. doi: 10.1002/sctm.17-0144. Epub 2017 Oct 24.


Human Germline Genome Editing.

Ormond KE, Mortlock DP, Scholes DT, Bombard Y, Brody LC, Faucett WA, Garrison NA, Hercher L, Isasi R, Middleton A, Musunuru K, Shriner D, Virani A, Young CE.

Am J Hum Genet. 2017 Aug 3;101(2):167-176. doi: 10.1016/j.ajhg.2017.06.012. Review.


Mitochondrial Replacement Therapy: The Road to the Clinic in Canada.

Knoppers BM, Leader A, Hume S, Shoubridge EA, Isasi R, Noohi F, Ogbogu U, Ravitsky V, Kleiderman E.

J Obstet Gynaecol Can. 2017 Oct;39(10):916-918. doi: 10.1016/j.jogc.2017.05.007. Epub 2017 Jul 18. No abstract available.


Uncertainty and innovation: Understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environments.

Isasi R, Rahimzadeh V, Charlebois K.

Appl Transl Genom. 2016 Nov 11;11:27-39. doi: 10.1016/j.atg.2016.11.001. eCollection 2016 Dec.


Community genetics: Genetics boosts US-Cuban links.

Isasi R, Zuchner SL, Villafranca RC.

Nature. 2016 Nov 17;539(7629):357. doi: 10.1038/539357d. No abstract available.


GENETIC TECHNOLOGY REGULATION. Editing policy to fit the genome?

Isasi R, Kleiderman E, Knoppers BM.

Science. 2016 Jan 22;351(6271):337-9. doi: 10.1126/science.aad6778. No abstract available.


Data sharing in stem cell translational science: policy statement by the International Stem Cell Forum Ethics Working Party.

Bredenoord AL, Mostert M, Isasi R, Knoppers BM.

Regen Med. 2015;10(7):857-61. doi: 10.2217/rme.15.42. Epub 2015 Oct 27.


Developing Educational Resources to Advance Umbilical Cord Blood Banking and Research: A Canadian Perspective.

Beak CP, Chargé SB, Isasi R, Knoppers BM.

J Obstet Gynaecol Can. 2015 May;37(5):443-450. doi: 10.1016/S1701-2163(15)30260-7.


CRISPR germline engineering--the community speaks.

Bosley KS, Botchan M, Bredenoord AL, Carroll D, Charo RA, Charpentier E, Cohen R, Corn J, Doudna J, Feng G, Greely HT, Isasi R, Ji W, Kim JS, Knoppers B, Lanphier E, Li J, Lovell-Badge R, Martin GS, Moreno J, Naldini L, Pera M, Perry AC, Venter JC, Zhang F, Zhou Q.

Nat Biotechnol. 2015 May;33(5):478-86. doi: 10.1038/nbt.3227. No abstract available.


Oversight of human inheritable genome modification.

Isasi R, Knoppers BM.

Nat Biotechnol. 2015 May;33(5):454-5. doi: 10.1038/nbt.3231. No abstract available.


Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI).

Andrews PW, Baker D, Benvinisty N, Miranda B, Bruce K, Brüstle O, Choi M, Choi YM, Crook JM, de Sousa PA, Dvorak P, Freund C, Firpo M, Furue MK, Gokhale P, Ha HY, Han E, Haupt S, Healy L, Hei DJ, Hovatta O, Hunt C, Hwang SM, Inamdar MS, Isasi RM, Jaconi M, Jekerle V, Kamthorn P, Kibbey MC, Knezevic I, Knowles BB, Koo SK, Laabi Y, Leopoldo L, Liu P, Lomax GP, Loring JF, Ludwig TE, Montgomery K, Mummery C, Nagy A, Nakamura Y, Nakatsuji N, Oh S, Oh SK, Otonkoski T, Pera M, Peschanski M, Pranke P, Rajala KM, Rao M, Ruttachuk R, Reubinoff B, Ricco L, Rooke H, Sipp D, Stacey GN, Suemori H, Takahashi TA, Takada K, Talib S, Tannenbaum S, Yuan BZ, Zeng F, Zhou Q.

Regen Med. 2015;10(2 Suppl):1-44. doi: 10.2217/rme.14.93. No abstract available.


The DISCUSS Project: Revised Points to Consider for the Derivation of Induced Pluripotent Stem Cell Lines From Previously Collected Research Specimens.

Lomax GP, Hull SC, Isasi R.

Stem Cells Transl Med. 2015 Feb;4(2):123-9. doi: 10.5966/sctm.2014-0192. Epub 2015 Jan 5. Review.


Research ethics and stem cells: Is it time to re-think current approaches to oversight?

Caulfield T, Kamenova K, Ogbogu U, Zarzeczny A, Baltz J, Benjaminy S, Cassar PA, Clark M, Isasi R, Knoppers B, Knowles L, Korbutt G, Lavery JV, Lomax GP, Master Z, McDonald M, Preto N, Toews M.

EMBO Rep. 2015 Jan;16(1):2-6. doi: 10.15252/embr.201439819. Epub 2014 Dec 4. No abstract available.


CellCAN: a unique enabler of regenerative medicine and cell therapy in Canada.

Roy DC, Alarco AM, Isasi R.

Stem Cells Dev. 2014 Dec;23 Suppl 1:24-8. doi: 10.1089/scd.2014.0354.


Identifiability and privacy in pluripotent stem cell research.

Isasi R, Andrews PW, Baltz JM, Bredenoord AL, Burton P, Chiu IM, Hull SC, Jung JW, Kurtz A, Lomax G, Ludwig T, McDonald M, Morris C, Ng HH, Rooke H, Sharma A, Stacey GN, Williams C, Zeng F, Knoppers BM.

Cell Stem Cell. 2014 Apr 3;14(4):427-30. doi: 10.1016/j.stem.2014.03.014.


Stem cell research funding policies and dynamic innovation: a survey of open access and commercialization requirements.

Lévesque M, Kim JR, Isasi R, Knoppers BM, Plomer A, Joly Y.

Stem Cell Rev Rep. 2014 Aug;10(4):455-71. doi: 10.1007/s12015-014-9504-5.


A review of the key issues associated with the commercialization of biobanks.

Caulfield T, Burningham S, Joly Y, Master Z, Shabani M, Borry P, Becker A, Burgess M, Calder K, Critchley C, Edwards K, Fullerton SM, Gottweis H, Hyde-Lay R, Illes J, Isasi R, Kato K, Kaye J, Knoppers B, Lynch J, McGuire A, Meslin E, Nicol D, O'Doherty K, Ogbogu U, Otlowski M, Pullman D, Ries N, Scott C, Sears M, Wallace H, Zawati MH.

J Law Biosci. 2014 Feb 25;1(1):94-110. eCollection 2014 Mar. No abstract available.


Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

Ogbogu U, Burningham S, Ollenberger A, Calder K, Du L, El Emam K, Hyde-Lay R, Isasi R, Joly Y, Kerr I, Malin B, McDonald M, Penney S, Piat G, Roy DC, Sugarman J, Vercauteren S, Verhenneman G, West L, Caulfield T.

BMC Med Ethics. 2014 Feb 3;15:7. doi: 10.1186/1472-6939-15-7.


Fostering public cord blood banking and research in Canada.

Isasi R, Dalpe G, Knoppers BM.

Stem Cells Dev. 2013 Dec;22 Suppl 1:29-34. doi: 10.1089/scd.2013.0381.


The DISCUSS Project: induced pluripotent stem cell lines from previously collected research biospecimens and informed consent: points to consider.

Lomax GP, Hull SC, Lowenthal J, Rao M, Isasi R.

Stem Cells Transl Med. 2013 Oct;2(10):727-30. doi: 10.5966/sctm.2013-0099. Epub 2013 Aug 29.


Enabling advanced cell therapies (EnACT): invitation to an online forum on resolving barriers to clinical translation.

Bubela T, Reshef A, Li MD, Atkins H, Caulfield T, Culme-Seymour E, Gold ER, Illes J, Isasi R, McCabe C, Ogbogu U, Piret J, Mason C.

Regen Med. 2012 Nov;7(6):735-40. doi: 10.2217/rme.12.59. Epub 2012 Oct 1. No abstract available.


Disclosure and management of research findings in stem cell research and banking: policy statement.

Isasi R, Knoppers BM, Andrews PW, Bredenoord A, Colman A, Hin LE, Hull S, Kim OJ, Lomax G, Morris C, Sipp D, Stacey G, Wahlstrom J, Zeng F; International Stem Cell Forum Ethics Working Party.

Regen Med. 2012 May;7(3):439-48. doi: 10.2217/rme.12.23.


Sustained interaction: the new normal for stem cell repositories?

Isasi R, Knoppers BM, Lomax G.

Regen Med. 2011 Nov;6(6):783-92. doi: 10.2217/rme.11.93. Review.


Global update: Canada.

Willemse L, Isasi R, Lyall D.

Regen Med. 2011 Nov;6(6 Suppl):140-3. doi: 10.2217/rme.11.71. Review.


From banking to international governance: fostering innovation in stem cell research.

Isasi R, Knoppers BM.

Stem Cells Int. 2011;2011:498132. doi: 10.4061/2011/498132. Epub 2011 Sep 5.


[HumGen in Spain: a legislative and political tool in human genomics and public health].

Oliva-Sánchez PF, Zaga-Galante J, Arellano-Méndez A, Millet-Hassey F, Rosenthal-Peretzman J, Isasi R.

Rev Panam Salud Publica. 2011 Jun;29(6):475-6. Spanish. No abstract available.


Publishing SNP genotypes of human embryonic stem cell lines: policy statement of the International Stem Cell Forum Ethics Working Party.

Knoppers BM, Isasi R, Benvenisty N, Kim OJ, Lomax G, Morris C, Murray TH, Lee EH, Perry M, Richardson G, Sipp D, Tanner K, Wahlström J, de Wert G, Zeng F.

Stem Cell Rev Rep. 2011 Sep;7(3):482-4. doi: 10.1007/s12015-010-9226-2.


Stem cell banking: between traceability and identifiability.

Knoppers BM, Isasi R.

Genome Med. 2010 Oct 5;2(10):73. doi: 10.1186/gm194.


Use of umbilical cord blood for stem cell research.

Bordet S, Nguyen TM, Knoppers BM, Isasi R.

J Obstet Gynaecol Can. 2010 Jan;32(1):58-61. doi: 10.1016/S1701-2163(16)34406-1.


Stem cell charter.

Knoppers BM, Isasi R, Willemse L.

Regen Med. 2010 Jan;5(1):5-6. doi: 10.2217/rme.09.84. No abstract available.


iPS cells: mapping the policy issues.

Zarzeczny A, Scott C, Hyun I, Bennett J, Chandler J, Chargé S, Heine H, Isasi R, Kato K, Lovell-Badge R, McNagny K, Pei D, Rossant J, Surani A, Taylor PL, Ogbogu U, Caulfield T.

Cell. 2009 Dec 11;139(6):1032-7. doi: 10.1016/j.cell.2009.11.039.


Haemophilia gene therapy: the patients' perspective.

Costea I, Isasi R, Knoppers BM, Lillicrap D.

Haemophilia. 2009 Sep;15(5):1159-61. doi: 10.1111/j.1365-2516.2009.02065.x. Epub 2009 Jul 10. No abstract available.


Governing stem cell banks and registries: emerging issues.

Isasi RM, Knoppers BM.

Stem Cell Res. 2009 Sep-Nov;3(2-3):96-105. doi: 10.1016/j.scr.2009.05.003. Epub 2009 May 25.


Policy interoperability in stem cell research: demystifying harmonization.

Isasi RM.

Stem Cell Rev Rep. 2009 Jun;5(2):108-15. doi: 10.1007/s12015-009-9067-z. Epub 2009 Mar 31. Review.


The stem cell research environment: a patchwork of patchworks.

Caulfield T, Zarzeczny A, McCormick J, Bubela T, Critchley C, Einsiedel E, Galipeau J, Harmon S, Huynh M, Hyun I, Illes J, Isasi R, Joly Y, Laurie G, Lomax G, Longstaff H, McDonald M, Murdoch C, Ogbogu U, Owen-Smith J, Pattinson S, Premji S, von Tigerstrom B, Winickoff DE.

Stem Cell Rev Rep. 2009 Jun;5(2):82-8. doi: 10.1007/s12015-009-9071-3. Epub 2009 May 27. Review.


The human embryo: ethical and legal aspects.

Knoppers BM, Bordet S, Isasi R.

Methods Mol Biol. 2009;550:281-305. doi: 10.1007/978-1-60327-009-0_18.


Catalyzing umbilical cord blood research in Canada: a survey of current needs and practices of principal investigators.

Geransar RM, Einsiedel EF, Galipeau J, Isasi R, Sheremeta L, Knoppers BM.

J Obstet Gynaecol Can. 2009 Jan;31(1):63-71. No abstract available.


The use of fresh embryos in stem cell research: ethical and policy issues.

Cohen CB, Brandhorst B, Nagy A, Leader A, Dickens B, Isasi RM, Evans D, Knoppers BM.

Cell Stem Cell. 2008 May 8;2(5):416-21. doi: 10.1016/j.stem.2008.04.002.

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